Dan Meyer and his wife Kristina. Dan had a recalled Riata lead connected to his heart device which he had removed and replaced. Here he showed the location of the device in his chest.

Glen Stubbe, Star Tribune

St. Jude faults study's death tally, seeks retraction

Article by: JAMES WALSH

Star Tribune

April 6, 2012 - 9:12 PM

St. Jude Medical Inc. on Friday asked for a retraction of an article by a renowned cardiologist, saying it contains inaccuracies and a biased comparison of deaths attributed to its Riata leads with those made by Medtronic Inc.

In a release posted on its website, Little Canada-based St. Jude said Dr. Robert Hauser's article, published online last month by the Heart Rhythm Journal, is "mistaken or misleading." Hauser is a consulting cardiologist at Abbott Northwestern Hospital's Minneapolis Heart Institute.

Hauser used data in the U.S. Food and Drug Administration's Manufacturers and User Facility Device Experience (MAUDE) database to analyze deaths attributed to St. Jude's Riata leads and Medtronic's Quattro Secure leads. Leads are wires that connect implantable defibrillators to the heart.

St. Jude Medical said it was not consulted before publication and was not asked to validate the MAUDE data using its analyses of leads that had been returned to the medical device maker.

"Since the manuscript was published, the company has spent more than 300 hours attempting to reach the same conclusions as Dr. Hauser, but can find no way of analyzing the MAUDE database that reproduces the same numbers reported in the manuscript," St. Jude said.

Hauser's article classified the deaths as lead-related, indeterminate or not lead-related, and compared Riata leads with Medtronic's Quattro Secure leads. In December 2010, St. Jude took Riata leads off the market after wires were found to have protruded through the leads' outer insulation. The device has since been recalled. Fridley-based Medtronic continues to sell Quattro Secure leads.

St. Jude said that, "using the same search criteria outlined in the manuscript, the company has identified that Dr. Hauser's research substantially undercounted total deaths in the MAUDE database for Quattro Secure, which therefore resulted in substantial errors related to how Riata and Riata ST leads compared to the Quattro Secure lead." St. Jude said it found 377 reports of deaths involving Quattro Secure leads, not 62 as stated in Hauser's article.

To that, St. Jude responded, "We would again point out that Dr. Hauser's conclusions are based on a flawed and biased analysis and a comparison of inaccurate data."

Heart Rhythm Journal editors did not respond to a call seeking comment. Christopher Garland, a Medtronic spokesman, said the company is looking into the matter, but "this appears to be nothing more than a difference of opinion between St. Jude Medical and Dr. Hauser." He called the Quattro lead "the world's most reliable defibrillation lead."